Maternal DistressNCT06663397
Laughter Yoga's Impact on Traumatic Childbirth Preparation
A study testing Laughter Yoga and Standard Childbirth Preparation Training in people with Maternal Distress and Prenatal Stress, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted as a single-center, parallel-group, randomized controlled intervention trial to determine the effects of birth preparation training supported by laughter yoga on the perception of traumatic birth, fear of birth, prenatal depression, and attachment in primiparous women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Distress, Prenatal Stress, Pregnancy Related
- What is being tested?
- Laughter Yoga and Standard Childbirth Preparation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older.
- Pregnant individuals between 20-26 weeks of gestation (Childbirth preparation training should begin by the 20th week of pregnancy according to the recommendations of the Turkish Ministry of Health, and since the training is planned to last 4 weeks, participants will be recruited before entering the third trimester).
- First-time pregnancies.
- Individuals who understand, speak, and can read and write in Turkish.
- Women who consent to participate in the study.
Who cannot join
- Women with high-risk pregnancies (such as placenta previa, history of antepartum bleeding, ruptured membranes, preeclampsia, hypertension, diabetes, or other medical conditions, intrauterine growth restriction, multiple pregnancies, fetal anomalies, or any contraindications for normal vaginal delivery, substance or alcohol dependence, chronic illnesses, etc.).
- Individuals diagnosed with psychiatric disorders.
- Those who have received psychotherapy or medication within the last six months prior to the study.
- Pregnant women with prior training or experience in cognitive awareness-based or mind-body methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects Of Laughter Yoga-Supported Childbirth Preparation Training On Traumatic Birth Perception, Fear Of Birth, Prenatal Depression, And Attachment: A Randomized Controlled Study
This study will be conducted as a single-center, parallel-group, randomized controlled intervention trial to determine the effects of birth preparation training supported by laughter yoga on the perception of traumatic birth, fear of birth, prenatal depression, and attachment in primiparous women. The research population will consist of pregnant women who attend the Pregnancy Clinic of the Department of Obstetrics and Gynecology at Cebeci Medical Faculty, Ankara University. The study will involve two groups: the first group will receive birth preparation training supported by laughter yoga, while the second group will receive standard birth preparation training. A total of 68 pregnant women, 34 in each group, are planned to participate in the study. Data will be collected using the Introductory Information Form, Traumatic Birth Perception Scale, Prenatal Self-Assessment Scale Fear of Birth Subscale, Edinburgh Depression Scale, and Prenatal Attachment Inventory. These instruments will be administered to the participants three times: before the training, immediately after the training, and one month later. The research data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 24. Descriptive statistics (number, percentage, mean, standard deviation, minimum, and maximum values) will be used for data analysis. Independent samples t-test will be employed for comparisons between two independent groups, paired samples t-test will be used for repeated measures, one-way ANOVA will be used for comparisons among more than two groups, and Pearson correlation analysis will be applied for the relationship between two quantitative variables.
When data do not follow a normal distribution, the Mann-Whitney U test will be used for comparisons between two independent groups, the Wilcoxon signed-rank test will be used for repeated measures, the Kruskal-Wallis test will be used for comparisons among more than two groups, and Spearman correlation analysis will be used for the relationship between two quantitative variables. The reliability of the scales used in the study will be determined using Cronbach's alpha coefficient. Statistical significance will be set at p \< 0.05.
- Conditions
- Maternal Distress, Prenatal Stress, Pregnancy Related
- Being tested
- Laughter Yoga, Standard Childbirth Preparation Training
- Keywords
- Perception of Traumatic Birth, Fear of Childbirth, Prenatal Depression, Prenatal Attachment, Laughter Yoga, Childbirth Preparation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaOther
Laughter Yoga sessions lasting 45 minutes each week for a total of 4 sessions. These sessions will include 30 minutes of laughter and breathing exercises, followed by 15 minutes of laughter meditation and relaxation
Standard Childbirth Preparation TrainingOther
the sessions will be conducted in groups of 8 participants. Various educational materials, including visual aids, will be used, and the training will involve presentations, direct instruction, video displays, and question-and-answer sessions
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Laughter Yoga-Supported Childbirth Preparation Training) | Experimental | Similar to the control group, the training will be conducted by the researcher, covering the same content as the standard childbirth preparation training. However, in addition to this, the experimental group will participate in Laughter Yoga sessions lasting 45 minutes each week for a total of 4 sessions. These sessions will include 30 minutes of laughter and breathing exercises, followed by 15 minutes of laughter meditation and relaxation Receives: Other: Laughter Yoga; Other: Standard Childbirth Preparation Training |
| Control Group (Standard Childbirth Preparation Training) | Active comparator | The sessions will be conducted in groups of 8 participants. Various educational materials, including visual aids, will be used, and the training will involve presentations, direct instruction, video displays, and question-and-answer sessions. Receives: Other: Standard Childbirth Preparation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traumatic Birth Perception
- Traumatic Birth Perception Scale: Developed by Yalnız et al. (2016) to assess the level of traumatic birth perception among women of reproductive age, this scale consists of 13 items related to feelings of anxiety, fear, and worry when thinking about childbirth. Scoring ranges from 0 to 10 for each item, with a total possible score of 0 to 130. Higher scores indicate a greater perception of traumatic birth. The Cronbach's alpha reliability coefficient for this scale is 0.89 (Yalnız et al., 2017).
Measured: It will be administered three times: before the training, immediately after, and one month later.
Birth Fear
- Prenatal Self-Assessment Scale Birth Fear Subscale: This scale, developed by Lederman (1979), evaluates pregnant women's adjustment to motherhood. The Turkish reliability and validity study was conducted by Beydağ and Mete (2008). The Birth Fear Subscale consists of 10 items, with possible scores ranging from 10 to 40. Higher scores indicate greater fear of childbirth. The Cronbach's alpha reliability coefficient for this subscale is reported as 0.79 in Lederman's study and 0.84 in Beydağ and Mete's study.
Measured: It will be administered three times: before the training, immediately after, and one month later.
Prenatal Attachment
- Prenatal Attachment Inventory (PBE): Developed by Müller (1993) and adapted to Turkish by Yılmaz and Beji (2013), this 21-item scale assesses emotional experiences and attachment levels during pregnancy. Scores range from 21 to 84, with higher scores indicating stronger attachment. The Cronbach's alpha for this scale is 0.84 (Yılmaz \& Beji, 2013), and it will be administered at the same intervals.
Measured: It will be administered three times: before the training, immediately after, and one month later.
Prenatal Depression
- Edinburgh Depression Scale: Developed by Cox et al. (1987), this scale assesses the risk, level, and severity of postpartum depression. The Turkish validity and reliability study was conducted by Engindeniz et al. (1996), with an internal consistency coefficient of 0.79. The scale consists of 10 items rated on a 4-point Likert scale. Although designed for postpartum assessment, it will be used during pregnancy. The Cronbach's alpha coefficients for the three trimesters were 0.82, 0.83, and 0.84, respectively (Bergin et al., 2011).
Measured: It will be administered three times: before the training, immediately after, and one month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DistressStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center parallel-group randomized controlled trial study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Münevver Gönenç, Ankara University
- Investigators
- İlknur Gönenç, Assoc. Prof. Dr., Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663397
- Sponsor's protocol ID
- Ankara U
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared when requested and necessary.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Laughter Yoga-Supported Childbirth Preparation Training On Traumatic Birth Perception, Fear Of Birth, Prenatal Depression, And Attachment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06663397
- Acronym / sponsor ID
- Ankara U
- Conditions
- Maternal Distress, Prenatal Stress, Pregnancy Related
- Keywords
- Perception of Traumatic Birth, Fear of Childbirth, Prenatal Depression, Prenatal Attachment, Laughter Yoga, Childbirth Preparation Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted as a single-center, parallel-group, randomized controlled intervention trial to determine the effects of birth preparation training supported by laughter yoga on the perception of traumatic birth, fear of birth, prenatal depression, and attachment in primiparous women. The research population will consist of pregnant women who attend the Pregnancy Clinic of the Department of Obstetrics and Gynecology at Cebeci Medical Faculty, Ankara University. The study will involve two groups: the first group will receive birth preparation training supported by laughter yoga, while the second group will receive standard birth preparation training. A total of 68 pregnant women, 34 in each group, are planned to participate in the study. Data will be collected using the Introductory Information Form, Traumatic Birth Perception Scale, Prenatal Self-Assessment Scale Fear of Birth Subscale, Edinburgh Depression Scale, and Prenatal Attachment Inventory. These instruments will be administered to the participants three times: before the training, immediately after the training, and one month later. The research data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 24. Descriptive statistics (number, percentage, mean, standard deviation, minimum, and maximum values) will be used for data analysis. Independent samples t-test will be employed for comparisons between two independent groups, paired samples t-test will be used for repeated measures, one-way ANOVA will be used for comparisons among more than two groups, and Pearson correlation analysis will be applied for the relationship between two quantitative variables.
When data do not follow a normal distribution, the Mann-Whitney U test will be used for comparisons between two independent groups, the Wilcoxon signed-rank test will be used for repeated measures, the Kruskal-Wallis test will be used for comparisons among more than two groups, and Spearman correlation analysis will be used for the relationship between two quantitative variables. The reliability of the scales used in the study will be determined using Cronbach's alpha coefficient. Statistical significance will be set at p \< 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-center parallel-group randomized controlled trial study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Laughter Yoga-Supported Childbirth Preparation Training) | Experimental | Other: Laughter Yoga, Other: Standard Childbirth Preparation TrainingSimilar to the control group, the training will be conducted by the researcher, covering the same content as the standard childbirth preparation training. However, in addition to this, the experimental group will participate in Laughter Yoga sessions lasting 45 minutes each week for a total of 4 sessions. These sessions will include 30 minutes of laughter and breathing exercises, followed by 15 minutes of laughter meditation and relaxation |
| Control Group (Standard Childbirth Preparation Training) | Active comparator | Other: Standard Childbirth Preparation TrainingThe sessions will be conducted in groups of 8 participants. Various educational materials, including visual aids, will be used, and the training will involve presentations, direct instruction, video displays, and question-and-answer sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 years and older.
- Pregnant individuals between 20-26 weeks of gestation (Childbirth preparation training should begin by the 20th week of pregnancy according to the recommendations of the Turkish Ministry of Health, and since the training is planned to last 4 weeks, participants will be recruited before entering the third trimester).
- First-time pregnancies.
- Individuals who understand, speak, and can read and write in Turkish.
- Women who consent to participate in the study.
Key exclusion criteria (4 listed)
- Women with high-risk pregnancies (such as placenta previa, history of antepartum bleeding, ruptured membranes, preeclampsia, hypertension, diabetes, or other medical conditions, intrauterine growth restriction, multiple pregnancies, fetal anomalies, or any contraindications for normal vaginal delivery, substance or alcohol dependence, chronic illnesses, etc.).
- Individuals diagnosed with psychiatric disorders.
- Those who have received psychotherapy or medication within the last six months prior to the study.
- Pregnant women with prior training or experience in cognitive awareness-based or mind-body methods.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter YogaLaughter Yoga sessions lasting 45 minutes each week for a total of 4 sessions. These sessions will include 30 minutes of laughter and breathing exercises, followed by 15 minutes of laughter meditation and relaxation | Other | Experimental Group (Laughter Yoga-Supported Childbirth Preparation Training) |
| Standard Childbirth Preparation Trainingthe sessions will be conducted in groups of 8 participants. Various educational materials, including visual aids, will be used, and the training will involve presentations, direct instruction, video displays, and question-and-answer sessions | Other | Control Group (Standard Childbirth Preparation Training), Experimental Group (Laughter Yoga-Supported Childbirth Preparation Training) |
Primary outcome
Traumatic Birth Perception
Time frame: It will be administered three times: before the training, immediately after, and one month later.
• Traumatic Birth Perception Scale: Developed by Yalnız et al. (2016) to assess the level of traumatic birth perception among women of reproductive age, this scale consists of 13 items related to feelings of anxiety, fear, and worry when thinking about childbirth. Scoring ranges from 0 to 10 for each item, with a total possible score of 0 to 130. Higher scores indicate a greater perception of traumatic birth. The Cronbach's alpha reliability coefficient for this scale is 0.89 (Yalnız et al., 2017).
Birth Fear
Time frame: It will be administered three times: before the training, immediately after, and one month later.
• Prenatal Self-Assessment Scale Birth Fear Subscale: This scale, developed by Lederman (1979), evaluates pregnant women's adjustment to motherhood. The Turkish reliability and validity study was conducted by Beydağ and Mete (2008). The Birth Fear Subscale consists of 10 items, with possible scores ranging from 10 to 40. Higher scores indicate greater fear of childbirth. The Cronbach's alpha reliability coefficient for this subscale is reported as 0.79 in Lederman's study and 0.84 in Beydağ and Mete's study.
Prenatal Attachment
Time frame: It will be administered three times: before the training, immediately after, and one month later.
• Prenatal Attachment Inventory (PBE): Developed by Müller (1993) and adapted to Turkish by Yılmaz and Beji (2013), this 21-item scale assesses emotional experiences and attachment levels during pregnancy. Scores range from 21 to 84, with higher scores indicating stronger attachment. The Cronbach's alpha for this scale is 0.84 (Yılmaz \& Beji, 2013), and it will be administered at the same intervals.
Prenatal Depression
Time frame: It will be administered three times: before the training, immediately after, and one month later.
• Edinburgh Depression Scale: Developed by Cox et al. (1987), this scale assesses the risk, level, and severity of postpartum depression. The Turkish validity and reliability study was conducted by Engindeniz et al. (1996), with an internal consistency coefficient of 0.79. The scale consists of 10 items rated on a 4-point Likert scale. Although designed for postpartum assessment, it will be used during pregnancy. The Cronbach's alpha coefficients for the three trimesters were 0.82, 0.83, and 0.84, respectively (Bergin et al., 2011).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No. Data will be shared when requested and necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlknur Gönenç, Assoc. Prof. Dr. study chair
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga and Standard Childbirth Preparation Training in people with Maternal Distress and Prenatal Stress, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serkan Yılmaz, Prof.Dr. (03123191450, Yilmaz.Serkan@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic Birth Perception (time frame: It will be administered three times: before the training, immediately after, and one month later.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.